Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial.

BACKGROUND: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI. AIMS: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance. METHODS: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCR-guided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI. RESULTS: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6±44.4 ml vs 90.8±55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7±4.7 vs 11.7±7.6 in the control group; p<0.001). CONCLUSIONS: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614).

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry.

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Functional coronary angiography for the assessment of the epicardial vessels and the microcirculation.

Over the last decade, steady progress has been made in the ability to assess coronary stenosis relevance by merging computerised analyses of angiograms with fluid dynamic modelling. The new field of functional coronary angiography (FCA) has attracted the attention of both clinical and interventional cardiologists as it anticipates a new era of facilitated physiological assessment of coronary artery disease, without the need for intracoronary instrumentation or vasodilator drug administration, and an increased adoption of ischaemia-driven revascularisation. This state-of-the-art review performs a deep dive into the foundations and rationale behind FCA indices derived from either invasive or computed angiograms. We discuss the currently available FCA systems, the evidence supporting their use, and the specific clinical scenarios in which FCA might facilitate patient management. Finally, the rapidly growing application of FCA to the diagnosis of coronary microvascular dysfunction is discussed. Overall, we aim to provide a state-of-the-art review not only to digest the achievements made so far in FCA, but also to enable the reader to follow the many publications and developments in this field that will likely take place in years to come.

Procedural and Technological Innovations Facilitating Ultra-low Contrast Percutaneous Coronary Interventions.

Ultra-low-dose contrast percutaneous coronary intervention (PCI) is a valuable approach in selected complex high-risk patients with renal failure. One of the objectives of ultra-low contrast PCI is to decrease the probability of developing postprocedural contrast-induced nephropathy (CIN), which predominately affects patients with baseline renal dysfunction. CIN is associated with poor clinical outcomes and increased healthcare-related costs. Another two clinical scenarios in which reduced dependence on contrast administration by the operator may contribute to improved safety are PCI in complex, high-risk indicated patients and in shock. In this review, we discuss the procedural techniques and recent technological innovations that enable ultra-low-dose contrast PCI to be performed in the cardiac cath lab.

Propensity-matched analysis of long-term clinical results after ostial circumflex revascularisation.

BACKGROUND: Percutaneous coronary intervention (PCI) of the ostium of the left circumflex artery (LCx) is technically challenging. The aim of this study was to compare long-term clinical outcomes of ostial PCI located in the LCx versus the left anterior descending artery (LAD) in a propensity-matched population. METHODS: Consecutive patients with a symptomatic isolated 'de novo' ostial lesion of the LCx or LAD treated with PCI were included. Patients with a stenosis of >40% in the left main (LM) were excluded. A propensity score matching was performed to compare both groups. The primary endpoint was target lesion revascularisation (TLR); other endpoints included target lesion failure and an analysis of the bifurcation angles. RESULTS: From 2004 to 2018, 287 consecutive patients with LAD (n=240) or LCx (n=47) ostial lesions treated with PCI were analysed. After the adjustment, 47 matched pairs were obtained. The mean age was 72±12 years and 82% were male. The LM-LAD angle was significantly wider than the LM-LCx angle (128°±23° vs 108°±24°, p=0.002). At a median follow-up of 5.5 (IQR 1.5-9.3) years, the rate of TLR was significantly higher in the LCx group (15% vs 2%); with an HR of 7.5, 95% CI 2.1 to 26.4, p<0.001. Interestingly, in the LCx group, TLR-LM occurred in 43% of the TLR cases; meanwhile, no TLR-LM involvement was found in the LAD group. CONCLUSIONS: Isolated ostial LCx PCI was associated with an increase in the rate of TLR compared with ostial LAD PCI at long-term follow-up. Larger studies evaluating the optimal percutaneous approach at this location are needed.

Duration and clinical outcomes of dual antiplatelet therapy following percutaneous coronary intervention for acute coronary syndrome: A multicentre "real-world practice" registry-based study.

Background: The optimal duration of dual antiplatelet therapy (DAPT) ought to be determined taking into account individual ischaemic or bleeding events risks. To date, studies have provided inconclusive evidence on the effects of prolonged DAPT. We sought to evaluate the long-term outcomes of this strategy following percutaneous revascularization in the context of acute coronary syndrome (ACS). Methods: Retrospectively from four centers in Madrid, we identified 750 consecutive ACS patients, divided in two groups of DAPT duration: <13 months and >13 months, with a mean follow-up of 48 months. Results: Patients with DAPT > 13 months had a higher non-adjusted incidence of Major Adverse Cardiovascular Events (11.6% vs. 17.3%) and new revascularization (3.7% vs. 8.7%). Differences in all-cause death, cardiac death, myocardial infarction, stent thrombosis and stroke were non-significant. There was no difference in the incidence of major bleeding (7.4% vs. 6.3%). Multivariable Cox regression analysis showed that the independent risk predictors of MACE were age (HR: 1.04, 95% CI: 1.02-1.06, p < 0.001) and multivessel disease (HR: 2.29, 95% CI: 1.32-3.95, p = 0.003), whereas the independent protective predictor was normal hemoglobin (HR: 0.88, 95% CI: 0.78-0.98, p = 0.022). Conclusions: In this real-world registry cohort of ACS patients treated with PCI and 1 year of DAPT in Spain, we report a trend of increased rate of MACE and new revascularization not associated with TVR in patients with longer DAPT. Our findings support the need for future randomized controlled trials to confirm or refute these results.

Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial.

BACKGROUND: The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI. STUDY DESIGN AND OBJECTIVES: The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled. CONCLUSIONS: The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov/ct2/show/NCT04085614.

Contemporary percutaneous management of coronary calcification: current status and future directions.

Severe coronary artery calcification is one of the greatest challenges in attaining success in percutaneous coronary intervention, limiting acute and long-term results. In many cases, plaque preparation is a critical prerequisite for delivery of devices across calcific stenoses and also to achieve adequate luminal dimensions. Recent advances in intracoronary imaging and adjunctive technologies now allow the operator to select the most appropriate strategy in each individual case. In this review, we will revisit the distinct advantages of a complete assessment of coronary artery calcification with imaging and application of appropriate and contemporary plaque modification technologies in achieving durable results in this complex lesion subset.

Machine learning for prediction of all-cause mortality after transcatheter aortic valve implantation.

AIMS: Prediction of adverse events in mid-term follow-up after transcatheter aortic valve implantation (TAVI) is challenging. We sought to develop and validate a machine learning model for prediction of 1-year all-cause mortality in patients who underwent TAVI and were discharged following the index procedure. METHODS AND RESULTS: The model was developed on data of patients who underwent TAVI at a high-volume centre between January 2013 and March 2019. Machine learning by extreme gradient boosting was trained and tested with repeated 10-fold hold-out testing using 34 pre- and 25 peri-procedural clinical variables. External validation was performed on unseen data from two other independent high-volume TAVI centres. Six hundred four patients (43% men, 81 ± 5 years old, EuroSCORE II 4.8 [3.0-6.3]%) in the derivation and 823 patients (46% men, 82 ± 5 years old, EuroSCORE II 4.7 [2.9-6.0]%) in the validation cohort underwent TAVI and were discharged home following the index procedure. Over the 12 months of follow-up, 68 (11%) and 95 (12%) subjects died in the derivation and validation cohorts, respectively. In external validation, the machine learning model had an area under the receiver-operator curve of 0.82 (0.78-0.87) for prediction of 1-year all-cause mortality following hospital discharge after TAVI, which was superior to pre- and peri-procedural clinical variables including age 0.52 (0.46-0.59) and the EuroSCORE II 0.57 (0.51-0.64), P < 0.001 for a difference. CONCLUSION: Machine learning based on readily available clinical data allows accurate prediction of 1-year all-cause mortality following a successful TAVI.

Transvascular Balloon Occlusion: A Novel Bailout Strategy in Large Left Main Perforations.

Several complications have been reported in rotational atherectomy, and these complications are closely associated with cardiac tamponade, emergent surgery, and death. Here we describe a case of left main coronary artery, bullet-like perforation treated with a novel approach-transvascular balloon occlusion. (Level of Difficulty: Advanced.).

Acute Ischaemic Mitral Valve Regurgitation.

Acute ischaemic mitral regurgitation (IMR) is an increasingly rare and challenging complication following acute myocardial infarction. Despite recent technical advances in both surgical and percutaneous interventions, a poor prognosis is often associated with this challenging patient cohort. In this review, we revisit the diagnosis and typical echocardiographic features, and evaluate current surgical and percutaneous treatment options for patients with acute IMR.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Transcatheter Treatment of Mitral Regurgitation.

Mitral valve disease, and in particular mitral regurgitation, is a common clinical entity. Until recently, surgical repair and replacement were the only therapeutic options available, leaving many patients untreated mostly due to excessive surgical risk. Over the last number of years, huge strides have been made regarding percutaneous, catheter-based solutions for mitral valve disease. Transcatheter repair procedures have most commonly been used, and in recent years there has been exponential growth in the number of devices available for transcatheter mitral valve replacement. Furthermore, the evolution of these devices has resulted in both smaller delivery systems and a shift towards transeptal access, negating the need for surgical incisions. In line with these advancements, and clinical trials demonstrating promising outcomes in carefully selected cases, recent guidelines have strengthened their recommendations for these devices. It is appropriate, therefore, to now review the current transcatheter repair and replacement devices available and the evidence for their use.

Contemporary use of coronary computed tomography angiography in the planning of percutaneous coronary intervention.

Planning of percutaneous coronary interventions (PCI) is largely based on anatomical information obtained with invasive coronary angiography. Over the last decade, intracoronary information obtained from both imaging and physiological techniques has gradually gained recognition for this purpose. Yet, coronary computed tomography angiography (CCTA) is still ignored by most interventionalists as a tool in the planning of PCI strategies. This has occurred despite major developments in CCTA, including physiological assessment, plaque characterisation, etc. Furthermore, it is foreseeable that many more patients referred to the catheterisation laboratory will have had a prior CCTA study. In this review we discuss the distinct advantages provided by CCTA in studying coronary artery structure and function. We revisit the most frequent scenarios of complex PCI and establish analogies between the use of intracoronary diagnostics and CCTA in setting procedural strategy, and in anticipating specific challenges.

Non-ST-segment elevation myocardial infarction with evidence of transmural infarction complicated by left ventricular rupture during percutaneous coronary intervention.

We report a case of a 68-year-old man presenting with a non-ST-segment elevation myocardial infarction, complicated by fatal left ventricular free wall rupture with electromechanical disassociation and cardiac tamponade during percutaneous coronary intervention. The aetiology for the sudden haemodynamic collapse was initially unclear; however, transthoracic echocardiography confirmed pericardial tamponade and postmortem revealed complete transmural myocardial infarction with left ventricular free wall rupture. This serves as an important lesson that transmural infarction and subsequent mechanical complications, including ventricular rupture, can occur in non-ST-segment myocardial infarction and not just ST-segment myocardial infarction.